Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial

NCT03892967 | Completed Results

• 5 other identifiers: 18-007779NCI-2020-06973P30CA015083UM1CA233033E2C2
• Study Type: interventional
• Target: 50,207
• Locations: 1 country
• Sites: 1

Brief Summary

This early phase I trial investigates enhanced, electronic health record (EHR)-facilitated cancer system control. Cancer and its treatment are often associated with severe, disabling symptoms that have been causally linked to diminished survival, increased healthcare utilization, degraded quality of life, unemployment, and non-adherence to recommended cancer treatments. Collaborative case management for control of moderate or worse sleep disturbance, pain, anxiety, depression, fatigue (SPADE symptoms), and physical dysfunction among cancer survivors and patients with cancer may improve quality of life, symptom severity, and adherence to cancer treatment, and may also reduce need for acute care.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.

  Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment from baseline score were modeled jointly as a co-primary outcome.

  Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)

• Physical Function Numerical Rating Scale (NRS) Scores

  Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment following any NRS score of \>=4/10 modeled jointly as a co-primary outcome.

  Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)

Secondary Outcomes (7)

• Change in Anxiety Score

  Baseline to 46 months

• Change in Depression Score

  Baseline to 46 months

• Change in Average Pain Interference Over the Past Week

  Baseline to 46 months

• Change in Physical Function Score

  Baseline to 46 months

• Health Care Utilization

  Up to 46 months (beginning from a participants' index medical oncology encounter until death, 18 months after last clinical encounter, or end of study)

Study Arms (1)

Supportive care (interview)

EXPERIMENTAL

Patients randomized to E2C2 intervention participate in an interview over 30-45 minutes. Providers and stakeholders also participate in an interview over 15-30 minutes.

Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Interview OTHER

Participate in interview

Supportive care (interview)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (interview)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (interview)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being seen for a solid or liquid cancer at a Midwest Mayo Clinic Midwest Mayo Clinic Health Systems (MCHS) site or for a solid tumor at Mayo Clinic Rochester

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (7)

• Finney Rutten LJ, Ruddy KJ, Chlan LL, Griffin JM, Herrin J, Leppin AL, Pachman DR, Ridgeway JL, Rahman PA, Storlie CB, Wilson PM, Cheville AL. Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2). Trials. 2020 Jun 5;21(1):480. doi: 10.1186/s13063-020-04335-w.

  PMID: 32503661 BACKGROUND

• Cheville AL, Herrin J, Pachman DR, Grzegorczyk V, Kroenke K, Ridgeway JL, Minteer SA, Austin JD, Griffin JM, Chlan L, Tofthagen C, Mitchell SA, Smith A, Ruddy KJ. Electronic health record-facilitated symptom surveillance and collaborative care intervention in oncology (E2C2): a cluster-randomised, population-level, stepped-wedge, pragmatic trial. Lancet Oncol. 2026 Jan;27(1):125-136. doi: 10.1016/S1470-2045(25)00526-1. Epub 2025 Dec 1.

  PMID: 41344348 DERIVED

• Minteer SA, Ridgeway JL, Pachman DR, Austin JD, Griffin JM, Ruddy KJ, Cheville AL. Barriers and facilitators to using practice facilitators to implement a remote cancer symptom management intervention: a mixed methods study. BMC Health Serv Res. 2025 Sep 3;25(1):1189. doi: 10.1186/s12913-025-13378-1.

  PMID: 40903741 DERIVED

• Kuharic M, Merle JL, Cella D, Mitchell SA, DiMartino L, Ridgeway JL, Dizon DS, Paudel R, Austin JD, Wong SL, Flores AM, Cheville AL, Smith JD; IMPACT Consortium. Psychometric evaluation of the NoMAD instrument in cancer care settings: assessing factorial validity, measurement invariance, and differential item functioning. Implement Sci Commun. 2025 Jun 16;6(1):72. doi: 10.1186/s43058-025-00756-3.

  PMID: 40524282 DERIVED

• Austin JD, Finney Rutten LJ, Fischer K, Ridgeway J, Minteer S, Griffin JM, Pachman DR, Ruddy KJ, Cheville A. Advancing Care Team Adoption of Electronic Health Record Systems for Cancer Symptom Management: Findings From a Hybrid Type II, Cluster-Randomized, Stepped-Wedge Trial. JCO Oncol Pract. 2025 Feb;21(2):209-217. doi: 10.1200/OP.24.00280. Epub 2024 Aug 6.

  PMID: 39106420 DERIVED

• Ridgeway JL, Cheville AL, Fischer KJ, Tesch NK, Austin JD, Minteer SA, Pachman DR, Chlan LL, Ruddy KJ, Griffin JM. Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention. Contemp Clin Trials Commun. 2024 Feb 9;38:101269. doi: 10.1016/j.conctc.2024.101269. eCollection 2024 Apr.

  PMID: 38380342 DERIVED

• Kroenke K, Lam V, Ruddy KJ, Pachman DR, Herrin J, Rahman PA, Griffin JM, Cheville AL. Prevalence, Severity, and Co-Occurrence of SPPADE Symptoms in 31,866 Patients With Cancer. J Pain Symptom Manage. 2023 May;65(5):367-377. doi: 10.1016/j.jpainsymman.2023.01.020. Epub 2023 Feb 2.

  PMID: 36738867 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Andrea L. Cheville, MD
• Organization: Mayo Clinic

Cheville.Andrea@mayo.edu

507-284-1402

Study Officials

• Andrea L Cheville

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 27, 2019
• Study Start: March 28, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: October 7, 2025
• Results First Posted: October 7, 2025

Record last verified: 2025-05

Locations

US (1)